NOVASTEP

Address:2 allee Jacques Frimot,RENNES Bretagne,FR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Orthopedic Manual Surgical Instrument (LXH) (5) Pin, Fixation, Smooth (HTY) (4) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

LYNC - 03700879500447 Catalog Number : CM010020

Device Description : Lync L0

Device Class : 2

Duns Number: 264255288

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

LYNC - 03700879500454 Catalog Number : CM010021

Device Description : Lync L10

Device Class : 2

Duns Number: 264255288

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

NEXIS - 03700879500461 Catalog Number : XFP01001

Device Description : Scarf forceps

Device Class : 1

Duns Number: 264255288

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ARCAD - 03700879500485 Catalog Number : XDG01001

Device Description : Arcad 10 Drill Guide

Device Class : 1

Duns Number: 264255288

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ARCAD - 03700879500492 Catalog Number : XPP01001

Device Description : Arcad Positionning pin Ø2

Device Class : 1

Duns Number: 264255288

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

ARCAD - 03700879500508 Catalog Number : XMS01002

Device Description : Staples impactor

Device Class : 1

Duns Number: 264255288

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LYNC - 03700879500515 Catalog Number : XRA01001

Device Description : Lync proximal rasp

Device Class : 2

Duns Number: 264255288

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

LYNC - 03700879500522 Catalog Number : XRA01002

Device Description : Lync distal rasp

Device Class : 2

Duns Number: 264255288

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

NEXIS - 03700879500546 Catalog Number : XGA01001

Device Description : Nexis Ruler length 80

Device Class : 1

Duns Number: 264255288

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

NEXIS - 03700879500553 Catalog Number : XSD01001

Device Description : Nexis T7 AO screwdriver Tip

Device Class : 2

Duns Number: 264255288

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

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